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NCT Number: NCT04035044

Study of the Analytical Performance of ALLEGRO™ Instrument

A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. This means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. It is obviously important that this analyser performs to a similar degree of accuracy to the laboratory analyses.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

C-TRIC

Londonderry, BT476SB, United Kingdom

About this study

Blood and urine tests are used in the assessment of diabetes and to guide clinical management. In the traditional model of care, blood samples are taken from patients at the clinic and are sent to the laboratory for analysis and the results may not be available for a number of hours/days after the clinic visit.

A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. This means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. It is obviously important that this analyser performs to a similar degree of accuracy to the laboratory analyses.

The aim of this research study is to assess the accuracy of the Allegro™ analyser compared to laboratory analyses on finger prick capillary blood samples and urine samples. Fifty (50) patients with diabetes will be invited to give a venous blood sample, finger prick capillary blood sample and urine sample. The venous blood sample, finger prick capillary blood sample and urine sample will be analysed by both the Allegro™ analyser and laboratory analyses and the results compared. The Allegro™ results will not be used in the management of the patients' diabetes.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes patients attending Altnagelvin Area Hospital Clinics or primary care in Western Trust area aged 18-80 years of age

Exclusion criteria

  • Patients who are less than 18 years or over 80 years of age

Treatment and study plan

Primary outcomes

  1. Analytical verification of Allegro - HbA1c comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in mmol/mol

  2. Analytical verification of Allegro - Cholesterol comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Cholesterol blood results in mmol/L

  3. Analytical verification of Allegro - HDL comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HDL blood results in mmol/L

  4. Analytical verification of Allegro - Triglycerides comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Triglycerides blood results in mmol/L

  5. Analytical verification of Allegro - Glucose comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Glucose blood results in mmol/L

  6. Analytical verification of Allegro - Creatinine comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine blood results in mg/dL

  7. Analytical verification of Allegro - Urine creatinine comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine urine results in mg/dL

  8. Analytical verification of Allegro - Urine Albumin comparison

    Time frame: 10 minutes

    Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Albumin urine results in g/L

Sponsors and collaborators

Lead sponsor

Nova Biomedical

Industry

Collaborators

  • C-TRIC

Registry information

Official study title

Study of the Analytical Performance of ALLEGRO™ Instrument: Performance Evaluation of In Vitro Diagnostic Device

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2019
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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